Glenmark Pharmaceuticals’ US-based subsidiary -- Glenmark Pharmaceuticals Inc is recalling 2,404 bottles of Indomethacin Extended-Release Capsules, produced at a Madhya Pradesh plant, due to ‘Failed Dissolution Specifications’. Glenmark Pharmaceuticals Inc, USA initiated the Class II recall on July 31.
As per the USFDA, a Class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Glenmark Pharmaceuticals is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries.